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date: 30 November 2020

Health and Infectious Disease

Abstract and Keywords

The chapter offers a critical review of the development of a legal and political framework for the prevention and control of international disease outbreaks. Historically, such development focused on the role and functions of the World Health Organization, culminating in the 2005 revision of the International Health Regulations. The effectiveness of that framework has come under intense criticism as a result of the inadequate international response to the 2014–2016 Ebola outbreak in West Africa and has led to global efforts to build a more credible system of global health security. The chapter analyzes recent legal and policy developments in this area, with particular emphasis on the inclusion of health threats into the international security agenda and the complex interactions between the international protection of biodiversity and sharing of human pathogens for public health protection.

Keywords: WHO, International Health Regulations, Ebola, global health security, international disease outbreaks, international security, biodiversity, pandemics, epidemics, pathogens

Since time immemorial, governments and populations have confronted the prevention and control of infectious diseases, which have an inherently international dimension. Pathogens do not stop at national boundaries. International flows of persons, animals, and goods carry an implicit risk that communicable diseases will spread, rendering every country vulnerable. The growing appreciation of the inherently cross-cutting nature of health and its interactions with many areas of international law and governance have led to the development of innovative forms of international regulation and cooperation with regard to the prevention and control of infectious diseases. This chapter reviews the main international institutional and legal aspects of the fight against the international spread of diseases, with particular reference to the role of the World Health Organization (WHO) and other UN organizations.

International Cooperation and WHO’s Role

International cooperation began in earnest with the first International Sanitary Conference held in Paris in 1851, which aimed to adopt a convention to control the spread of cholera, plague, and yellow fever through maritime traffic. This event signaled the beginning of a century of intense diplomatic activity in the field of infectious diseases, marked by a large number of diplomatic conferences and an increasing number of regional and international conventions and regulations, some of which however never entered into force.1 The balance between the competing goals of protecting health and minimizing the restrictions to traffic and trade caused by quarantines and (p. 680) similar control measures was pursued through the setting of internationally agreed ‘maximum’ measures.

The development of a normative framework soon led to the establishment of permanent international institutions that performed a number of tasks requiring a more centralized approach. The patchwork nature of international cooperation led to the creation of several regional and global organizations performing similar functions including the Pan-American Sanitary Bureau in 1905 (later renamed Pan-American Health Organization, PAHO, and still in existence); the Office International d’Hygiène Publique in 1907; and the Health Organization of the League of Nations in 1919.

The establishment of WHO in 1948 represented a break in several respects from the previous approach to the control of infectious diseases. The main changes were fourfold. The first was the centralization into a single universal agency of the functions previously exercised by a number of international bureaux. The second were the striking normative powers entrusted to WHO. Articles 21 and 22 of the organization’s constitution, in particular, empower the World Health Assembly (WHA) to adopt legally binding regulations that enter into force automatically by a specified deadline for non-dissenting states in a number of areas, including on ‘sanitary and quarantine requirements and other procedures designed to prevent the international spread of disease.’ The third change was that the control of infectious diseases became an integral part of a broader and integrated constitutional mandate to pursue the most diverse aspects of public health, with particular regard to assisting poorer countries, which have historically been exporters of infectious diseases. The fourth was that the very concept of health changed radically from the narrow medical vision of the nineteenth century. Health is defined in WHO’s constitution as ‘a state of complete physical, mental and social well-being and not merely the absence of disease’; and the ‘enjoyment of the highest attainable standard of health’ is proclaimed as a fundamental human right.

WHO has historically tackled infectious diseases in a variety of ways within its constitutional mandate in Article 2 as the ‘directing and co-ordinating authority on international health work,’ mainly through policy, technical, and normative approaches. WHO’s policy approach has focused on the adoption and support of international strategies and frameworks addressing specific diseases, for example through holistic global health-sector strategies for HIV/AIDS and related pathologies such as viral hepatitis and sexually transmitted infections (most recently through WHA resolution 69.22 of 28 May 2016). Most importantly, it has meant framing the core function of fighting infectious diseases within a broader vision of health governance and most recently within the framework of the UN’s Sustainable Development Goals (SDGs).

In this context, the most important and long-lasting contribution of WHO has arguably been the ‘health for all’ process launched at the WHO–UNICEF 1978 Alma-Ata (now Almaty) conference on primary health care, as well as the reorientation of WHO’s activities and priorities underscoring that process.2 Primary health care is based on a number of crucial factors for the control of infectious diseases such as safe water and basic sanitation, immunization, and the prevention and control of locally endemic diseases. Vertical programs addressing specific diseases have therefore been integrated (p. 681) by horizontal programs focusing on health systems as a whole as well as on the institutional, social, and political determinants of health.

The recent emphasis by WHO and the UN on universal health coverage, which figures as one of the targets of Goal 3 of the SDGs, aims at securing universal affordable, sustainable and equitable access to essential quality health services.3 This goal-setting has a direct relevance for the topic of this chapter; experience from recent outbreaks confirms—as if there was a need—that the first condition for preventing the international spread of diseases is well-functioning, sustainable, and equitable national health systems. Horizontal and vertical programs play therefore a synergistic role in achieving global health security.

From a technical and operational point of view, WHO has focused on coordinating and catalyzing campaigns to eradicate or control a number of infectious diseases, from influenza to poliomyelitis and from childhood disease such as measles and whooping cough to a range of neglected tropical diseases such as onchocerciasis and leishmaniasis.4 WHO’s early success in controlling yaws in the 1950s induced a generalized but ill-founded optimism that the advances in medical sciences were heralding the end of epidemic diseases as a serious public health threat. The eradication of smallpox by 1977 undoubtedly was the major achievement of WHO to date, and poliomyelitis is tantalizingly close to eradication after decades of setbacks. At the same time, the organization’s campaigns have not effectively controlled malaria and tuberculosis; and, together with the rest of the UN system, WHO proved powerless to control the worldwide progression of the HIV/AIDS pandemic in the 1980s and 1990s.

WHO’s main normative tool is the International Health Regulations (IHR), initially adopted in 1951 and revised several times, most recently in 2005.5 The IHR represented the international response to the inadequacy of the pre-WHO legal regime, by replacing the patchwork of international sanitary agreements with a single global legal instrument managed by a dedicated international agency. The IHR were initially based on similar principles as those applicable to earlier conventions, such as being limited to an exhaustive list of diseases (eventually only cholera, plague, and yellow fever) which had to be notified to the other states parties through WHO. The IHR were also still premised on the provision of maximum measures applicable in general as well as for each listed disease.

The IHR initially provided a useful legal reference for routine measures but became increasingly marginal and inadequate and fell into desuetude. The disease-specific approach, in particular, made the IHR inapplicable to the growing number of emerging or re-emerging diseases that have characterized the late twentieth century. Moreover, the regulations did not protect reporting countries from unnecessary and damaging overreactions, while the approach of fixed maximum measures proved too rigid and inconsistent with the context-based approach of both trade and human rights treaties.6

The international community has, since the 1990s, been confronted with a growing problem of emerging and reemerging diseases and of their increasing resistance to available drugs. This is due partly to the emergence of new or mutating diseases such as coronaviruses, avian influenza, and hemorrhagic fevers, and partly to the state of (p. 682) neglect of many national health systems that are unable to act as the primary barriers against the international spread of diseases. The increasing speed and volume of international travel and trade moreover create the conditions for the rapid spread of such diseases, while the growing fears of a terrorist attack using biological or chemical agents has blurred the lines between public health action and national security and injected heightened political urgency into the former, as discussed below.

Confronted with this complex situation, exacerbated by the fear generated by the SARS outbreak, the WHA launched in 2013 an urgent revision process of the IHR, which was quickly and successfully completed with the adoption in May 2005 of a drastically revised instrument that entered into force in June 2007 and currently has 196 parties.7 The list of diseases is replaced by the open concept of ‘event,’8 which can be of biological, chemical, or nuclear source and of any origin (i.e., natural, accidental, or intentional). This approach requires WHO to go beyond ‘traditional’ infectious diseases, adapt its surveillance and response strategies, and cooperate with a number of international actors to manage overlaps and avoid gaps. Most importantly, it turns a public health instrument also into an early warning tool for terrorist acts, thus injecting an evident political dimension into its implementation.

Under Articles 5 and 6 of the IHR, states must assess all unusual health events occurring on their territory and notify WHO of all events that may constitute a ‘public health emergency of international concern’ (PHEIC).9 WHO is a central actor in the implementation of the revised IHR, with a dynamic role and strong normative and operational authority; the director-general, in particular, has the authority to declare a PHEIC and to issue temporary recommendations for its management and control. WHO may also rely on non-state sources of information and proactively disclose information on on-going events. States have a number of new obligations on surveillance, verification, cooperation, and information sharing, and also crucially to strengthen and maintain their own domestic capacities to detect, assess and respond to events (defined as ‘core capacities’). Rather than only focusing on points of entry such as ports and airports, the IHR penetrate deeper into a country’s management of its national health system, thus reflecting the awareness that global risks depend on local situations and capacities and not only on infrastructure at the border.

WHO’s determinations and recommendations, as well as national measures, have to be based on scientific evidence and a contextual risk assessment both to adapt to the specific circumstances of an unforeseeable range of events, and to ensure their consistency with the relevant World Trade Organization (WTO) agreements in cases of trade restrictions. The regulations also contain detailed provisions for the respect of human rights, the avoidance of unnecessarily intrusive measures, and the protection of personal data. The centralization of decision-making powers in WHO and the relative strictness of IHR-based obligations are counterbalanced by the parties’ right under Article 43 to apply national health measures going beyond WHO’s recommendations or even breaching some of their obligations when considered necessary to respond to PHEICs or public health risks. This possibility, subject to a rather timid monitoring by WHO staff, was the outcome of an extremely difficult negotiation. It reflects states’ (p. 683) ambivalence to transferring substantial authority to an international body in matters of potentially high political and sovereign importance.

While the more routine measures contained in Parts IV to VI of the IHR—and largely reflecting international best practices—have not raised particular problems, the surveillance and response provisions contained in Parts II and III have proved more problematic and their implementation by WHO at times controversial. The director-general has declared PHEICs on four occasions—in 2009 for the pandemic of H1N1 influenza, in 2014 for the spread of poliomyelitis as well as the outbreak of Ebola virus in West Africa, and in 2016 in response to the spread of Zika virus.10 The declarations were accompanied by temporary recommendations to guide and coordinate national and international responses including increased vaccination, to strengthen laboratory capacities and research efforts, to organize exit screening of international travelers, but also to avoid unnecessary measures such as suspension of flights or closure of borders.

WHO came under severe criticism from different perspectives; during the H1N1 influenza pandemic, it was accused of having overestimated the severity of the disease, confused and scared the world by relying on ‘pandemic phases’ overlapping with the PHEIC, and for lack of transparency and conflicts of interest benefiting the pharmaceutical industry. During the Ebola virus outbreak, conversely, it was criticized for its delay in declaring a PHEIC and for its initial failure in leading and coordinating the international response.11 The United Nations stepped in with the establishment by the Secretary-General in September 2014 of the first ever health-related UN field operation. The United Nations Mission for Emergency Ebola Response (UNMEER) was established by the Secretary-General rather than by the Security Council, as is the case for peacekeeping operations.12 The failure in responding promptly to the Ebola virus outbreak and the resultant panic that enveloped the whole world caused a veritable existential crisis about the chronic inability of the international community to prevent and respond effectively to major health emergencies.

Multiple academic and policy reviews of the Ebola crisis identified crucial shortcomings both within the IHR as well as of a systemic nature, and proposed reforms which are now partly underway.13 The main findings can be summarized under six headings. First, very few countries have the core capacities required under the IHR and there is insufficient political and financial commitment to sustain IHR implementation. Second, the WHO lacks operational capacity and culture and is not properly financed to jump-start response; its decentralized structure with very autonomous regions led by elected regional directors stands in the way of a unified response. Third, the international response suffers from a chronic lack not only of funding and human resources but also of coordination, with constant competition and duplication among stakeholders and the added challenge—very evident in the case of Ebola—of merging the two different operational cultures of humanitarian emergency and outbreak response. The institutionalized recourse to the Inter-Agency Standing Committee and the ‘cluster approach’ with their predefined roles and responsibilities across the UN system and its partners, did not function properly during the Ebola crisis. Fourth, the IHR lack a compliance monitoring mechanism to build confidence and increase accountability. (p. 684) The secretariat’s monitoring of core national capacities was initially based on an unrealistic self-assessment by countries which generated a distorted global picture. The IHR also lack a system to encourage compliance and to deter or sanction counterproductive overreactions by countries, which plagued the response to the Ebola crisis and isolated affected countries. Fifth, the IHR surveillance and response processes within WHO were perceived as under-resourced, non-transparent and vulnerable to political pressures and conflicts of interest. Sixth, event management was complicated by the binary nature of the IHR, which only rely on PHEICs for international alert and response and do not foresee intermediate steps short of a full-blown emergency.

Health and International Security

The link between health and security was underscored as early as 1946 in the preamble to the WHO’s constitution, which states that ‘the health of all peoples is fundamental to the attainment of peace and security.’ That link, largely lost during the Cold War, developed after the end of the Cold War together with the emergence of the concept of human security within the UN system.14

The growing attention to the health/security paradigm has evolved along three main lines. The first is represented in general terms by the broadening of the notion of international security and its extension to humanitarian and social issues which explicitly or implicitly include health. The increasing willingness of the Security Council to intervene in internal conflicts and to include massive human suffering as a component of threats to the peace under Charter Article 39 is emblematic in this respect. The intellectual elaboration of this approach was expressed in the 2004 report of the UN High-level Panel on Threats, Challenges and Change, which had been asked by Secretary-General Kofi Annan to review the meaning of security in the twenty-first century.15

The second line concerns the perceived impact of naturally occurring diseases on national and international security. The conceptualization of this concern in political terms originated from the spread of HIV/AIDS in sub-Saharan Africa predominantly through sexual transmission, and was driven by the assumption that the disease would lead to economic and institutional collapse and trigger mass displacement, regional instability and conflicts. The United States pioneered this trend by placing the resurgence of infectious diseases as a factor of concern in national security strategies since the 1990s.16 In January 2000, the Security Council devoted a day-long session to AIDS in Africa, the first ever meeting dedicated to a health topic.17 Even though the Council did not adopt a formal decision, there was a consensus that the AIDS pandemic posed a security threat of the greatest magnitude and that collective security in the twenty-first century had to encompass threats deriving from infectious diseases.

The third main line concerns the growing fear of bio-terrorism, especially since the sarin gas attack in Tokyo in 1995 and the anthrax scare in the United States in late 2001. The fear of terrorist groups spreading biological agents or contaminating the food or (p. 685) water supply have exacerbated the sense of vulnerability of many countries and the political urgency of strengthening national and international preparedness.

The common thread is that national and international public health surveillance and response mechanisms against infectious diseases have increasingly become instrumental to a ‘security paradigm’ that does not distinguish between natural and intentional spread of diseases. Public health systems become at the same time early warning tools of a possible bio-terrorist attacks as well as the first ‘line of defense’ against any form of disease spread. With regard to international institutions, the ‘securitization of health’ in policy and conceptual terms has been discussed in the UN as well as in the G7 and the Global Health Security Agenda established in 2014 under US leadership. The report of the UN High-level Panel on Threats, Challenges and Change,18 for example, envisaged Security Council cooperation with WHO in enforcing effective quarantine measures and ‘cordon operations,’ supporting the work of WHO ‘investigators,’ and mandating greater access for WHO personnel in extreme cases of disease outbreaks of natural or deliberate origin. The response to outbreaks was thus seen in enforcement terms and implied the unwillingness or inability of affected countries to cooperate in their control, in a way that echoes the parallel debate over the responsibility to protect.

The most explicit policy statement appears in the 2014 Security Council resolution 2177, which was unanimously adopted as part of the UN’s response to the Ebola crisis. The Council, in the preamble of the resolution, determined ‘that the unprecedented extent of the Ebola outbreak in Africa constitutes a threat to international peace and security’ in light of the political instability of the affected countries and of the risk ‘of civil unrest, social tensions and a deterioration of the political and security climate.’ The operative provisions, however, focus on the health situation as if they were part of a WHO resolution; they urge coordination, renewed efforts, and support and call upon states to implement temporary recommendations under the IHR. The value of the resolution is mostly symbolic, as an expression of the determination of the international community to collectively fight the scourge of Ebola and assist its victims. It is significant, however, that the resolution was adopted at all by the Security Council, since its purpose and content more obviously belonged in the General Assembly, which was in session at that time and which adopted the more timid resolution 69/1 on Ebola in September 2014.

The inclusion of health threats in the international security agenda is a fact and will be one of the drivers of the political discussions on global health governance; the return of health into the agenda of the G7 after a long hiatus,19 and into that of the G20 in 2017, confirms that global health is at the center of the political agenda. This development is credited for elevating the political profile of health problems nationally and internationally and for generating larger amounts of public funding,20 a trend exemplified by the exponential increase in HIV/AIDS funding—from $300 million in 1996 to $15.6 billion in 2008.21 The use of security forces, moreover, should ensure better logistical support and is necessary to control internal disturbances and enforce public health regulations at times of tension and panic.

At the same time, the incipient securitization of health is provoking a lively debate among scholars, some of whom point to possible contradictory consequences. One (p. 686) recurrent criticism is that available empirical data reject the assumption of a linkage between infectious diseases and conflict, including for extreme events such as the Spanish influenza epidemic in 1918–1919 and HIV/AIDS in Africa.22 The conceptual assumptions underpinning the securitization of health are therefore seen as flawed or manipulated for the political interests of powerful developed countries.

The second main criticism concerns the political and human risks of securitizing health against the lack of evident benefits. In particular, financial resources could be skewed in favour of a narrow range of interventions and actors (e.g. priority vaccination of armed and police forces seen as ‘first responders’ rather than medical personnel), to the detriment of those serious public health problems causing high mortality and morbidity but lacking a security profile. An example consists of the main non-communicable diseases (cancer, diabetes, respiratory, and cardiovascular diseases), which constitute up to 65 percent of global mortality but do not attract a comparable level of political attention and funding.23

From an institutional perspective, securitization would transfer authority and resources from civilian to security agencies that inevitably approach diseases with a logic of threat containment and elimination and a ‘quick-fix’ mentality that will not solve underlying long-term causes and risk undermining local governance. Moreover, there are high risks of unnecessary breaches of human rights and of turning affected individuals and communities into stigmatized threats. Critics point to the dramatic differences between the UN system’s successful approach to fighting HIV/AIDS in Africa—based on human rights and social participation—and the draconian and sometimes counterproductive measures implemented in the three countries affected by Ebola.24

The Quest for Global Health Security

The global soul-searching and multiple reviews triggered by the Ebola outbreak are a manifestation of the sense of urgency at the chronic vulnerability of the international community faced with the increasing frequency of spread of emerging and re-emerging pathogens. Notwithstanding inevitable differences, the recent reviews reach strikingly similar conclusions and point consistently to the need for fundamental reform. Some of these reviews are on-going as of May 2017 and so their outcome is unclear.

From a governance perspective, the central question is WHO’s role and the division of labor with other international bodies. WHO responded to widespread criticism about its failure to lead the international response to Ebola with an historical shift from an exclusive normative and supportive role to adding a capacity for health-emergency responses. It did so through the establishment of a dedicated and largely independent program cutting across the regional structure of the organization. The ‘WHO health emergency programme’ has substantially reoriented WHO’s activities and absorbed a significant percentage of its workforce, even though about half of its staff positions remained unfunded as of May 2017; it has also adopted elaborate operating procedures (p. 687) to standardize and coordinate response to a broad range of unpredictable emergencies and outbreaks, in keeping with the philosophy of the IHR. One of WHO’s greatest distortions is its funding structure, whereby only about 25 percent of its budget is funded through assessed contributions while the remaining part is entirely funded by voluntary contributions—these are often earmarked for specific activities and thus not appropriate for funding emergency response. The Executive Board, acting for the first time in January 2015 under the emergency powers entrusted to it by Article 28 of WHO’s constitution,25 established a $100 million contingency fund for immediate response needs. However, as of May 2017 the fund only had about $31 million26 and member states have so far refused to fund the new program through assessed contributions. This funding approach by major contributors—if maintained—risks weakening the independence and effectiveness of WHO’s response capacity. At the same time the World Bank is increasing its funding in this area, particularly through market-based financial instruments.

At a UN system level and among outside partners, coordination processes have existed for a long time in the form of the interagency standing committee and its cluster approach as well as through operational networks such as the Global Outbreak Alert and Response Network (GOARN).27 At the same time, the failure of this established system and of WHO’s leadership during the Ebola outbreak has prompted calls for a subordination of WHO and other specialized agencies or UN programs to central coordination by the Secretary-General.28

A significant development is the increasing role of other UN organizations in crucial areas of global health governance including norm-setting and management of health emergencies. The UN has taken center stage in global health policy-making since the 2000 Security Council meeting and the 2001 General Assembly special session on HIV/AIDS, culminating with the Security Council’s actions during the Ebola outbreak. The Assembly has notably adopted resolution 66/2 on non-communicable diseases (NCDs) in 2011 and on antimicrobial resistance in the 2016 resolution 71/3. Moreover, a standing item on health and foreign policy has been included in the Assembly’s agenda since 2009. WHO participates in preparatory processes and is assigned implementation tasks by the Assembly, such as setting targets and indicators for the control of NCDs. This transfer of responsibility is an eloquent testimony to the increasing politicization and complexity of many health issues that transcend the remit of WHO, still perceived as an essentially technical organization. Similarly, the World Bank has taken over the role of main financier of pandemic preparedness and response through the establishment in 2016 of an emergency pandemic financing facility that will fund response to outbreaks of a defined set of diseases affecting least-developed countries. The facility is designed to complement WHO’s contingency fund and ensure seamless support for the crucial early stages of outbreak response. Following an increasingly popular model to protect fragile countries from catastrophic risks, the facility will partly draw on the international reinsurance market.29 These and other similar developments point to an informal ‘bottom-up’ division of labor whereby WHO’s role is limited to its normative and evidence functions, supplemented now by a fledgling response capacity.

(p. 688) Reform proposals have focused on the main perceived weaknesses and flaws of the IHR. Any such assessment of the IHR must take into account its limited objectives and purpose so as to avoid unrealistic expectations, and also to situate it within broader outbreak prevention and response rather than viewing it in isolation. A recurring set of recommendations, for example, urges the strengthening of WHO’s resources and capacity to detect and respond to health emergencies; this has been achieved at least to a certain extent through the above-mentioned establishment of WHO’s emergency program. Another recurring recommendation concerns a global and verifiable strategic plan catalyzed by WHO to prioritize national implementation of the IHR and achieve sustainable funding of preparedness and national core capacities. The latter issue occupies a central place in all reviews and is at the same time the lynchpin and one of the major challenges for global health security. Reaching and maintaining core national capacities is not only imperative for disease control, but also an obligation under Articles 5 and 13 of the IHR. Many states have been unable to comply with them even after the seven-year grace period allowed by those articles for lack of resources;30 and as noted earlier, the IHR lacks a compliance assessment mechanism comparable to those mainstreamed in many international environmental agreements.

It is indicative of the prevailing political and security perspective that the main support for national core capacity assessment has come not from WHO but from the Global Health Security Agenda (GHSA), a voluntary network launched by the US in 2014 in reaction to the shortcomings revealed by the Ebola crisis.31 The GHSA developed a Joint External Evaluation Tool (JEET) based on national self-assessment supplemented by inputs from teams of experts; the resulting scorecard would facilitate priority-setting by national authorities and also be more appealing to international development donors.32 It is equally indicative that the IHR Review Committee established by the director-general to analyze the performance of the regulations during the Ebola crisis proposed in its report to the 2016 WHA that the WHO secretariat and member states adopt the JEET as their main assessment tool; and that the current annual consolidated reports on IHR implementation be supplemented by detailed information on core capacities development and IHR compliance to increase accountability and confidence-building.33

It is disappointing that there is no proposal to amend the IHR to incorporate a compliance assessment process into its framework. The search for ‘work-around measures’— e.g., for core capacities—may be more politically realistic, but risk weakening the credibility and integrity of the IHR as a legal instrument. The same can be said about the recommendation by the IHR Review Committee that the WHO secretariat introduce a new alert threshold lower than a PHEIC without a corresponding amendment of Article 12 of the IHR.34 The delicate issue of how to induce compliance with IHR notifications, cooperation, and event assessment obligations, while deterring excessive unilateral reactive national measures, has been one of the main lessons of the Ebola crisis. It is a paradoxical failure that one of the goals of the dynamic evidence-based approach of the revised IHR was precisely to avoid unnecessary stigmatization and encourage transparency and cooperation from affected countries. The generalized overreactions (p. 689) against the three countries mostly affected by Ebola, and the reluctance of some countries in reporting outbreaks of infectious diseases, have demonstrated the challenges in achieving that balance. The lack of an enforcement mechanism has been seen as a major weakness of the IHR and has prompted recommendations to report non-compliance to the Security Council or to introduce sanctions akin to those resulting from the WTO dispute settlement process.35 The IHR global implementation plan noted by the 2017 WHA decided to strengthen the monitoring system contained in Article 43 and to disclose non-compliance to the WHA and to the public through the WHO website.36 More aggressive and antagonistic forms of legal enforcement are evidently not part of the mindset of the public health community and probably not appropriate to the particular challenges of controlling infectious diseases.

Global health security goes beyond the immediate tools to detect and respond to outbreaks of infectious diseases. The complexity of the epidemiological risks facing a globalized world requires a broader range of factors that should ideally complement and strengthen each other. The most important ones are the international sharing of biological samples and genetic sequences of pathogens, the strengthening and acceleration of research and development of medical countermeasures at times of health emergencies, and the growing threat of antimicrobial resistance that is slowly but irreversibly rendering most existing antibiotics and antivirals ineffective. These factors, however, are some of the most legally and politically challenging in current global health governance. This chapter’s focus remains on pathogen-sharing, which is more immediately linked to the governance questions discussed above.

The need to share samples of human pathogens among laboratories and research centers in order to identify them and their genetic structure is of crucial importance to arrive quickly at diagnostics, vaccines, and antivirals. There is, however, no dedicated international legal instrument on this issue. Up to now, most of the activities in this area have been of an informal nature or regulated by the contractual practices of participating laboratories as well as by national legislation on biosecurity. The most institutionalized example of multilateral virus-sharing is the voluntary network of laboratories focusing exclusively on influenza viruses in cooperation with WHO, currently referred to as the Global Influenza Surveillance and Response System (GISRS). Its work leads, among other things, to the annual recommendations of seasonal influenza vaccines, but it has naturally expanded its surveillance to the growing threat of pandemic influenza, such as sub-type H5N1 (the so-called Avian Flu). Human influenza can be seasonal or pandemic. Seasonal influenza circulates every year during the winter months, separately in the northern and southern hemispheres; pandemic influenza means a novel influenza virus to which there is no immunity and that causes outbreaks outside of the normal influenza season.37 GISRS performs surveillance and response functions for both types of influenza.

This model of international cooperation was thrown into disarray by Indonesia’s sudden refusal in 2017 to share its human samples of H5N1 influenza with GISRS. Indonesia challenged the unfairness of the system, whereby developing countries were freely sharing their viral specimens but did not receive any benefit in return and were (p. 690) faced with exorbitant market prices for purchasing vaccines.38 Indonesia justified legally its refusal by claiming sovereignty over H5N1 viruses identified in its territory on the basis of the UN Convention on Biological Diversity (CBD), characterizing human pathogens as ‘genetic resources’ under its Article 2.39 Under Article 15, access to genetic resources requires mutually agreed terms including the fair and equitable sharing of benefits arising from the utilization of those resources. The CBD’s approach is essentially bilateral and revolves around sovereignty over natural resources as its foundational principle; public health response instead arguably warrants quick, multilateral and unconditional sharing among laboratories, public agencies, and pharmaceutical companies. It should also be noted that the IHR do not impose an explicit obligation to share pathogens, even though it could arguably be derived from the general obligation to cooperate in good faith underpinning the whole instrument. That interpretation would apply in particular when sharing is essential to enable surveillance and response and is functional to the characteristics of a specific pathogen as in the case of influenza.

Indonesia’s stance, supported by other developing countries, led the WHA to the 2011 adoption of the non-legally binding Pandemic Influenza Preparedness Framework (PIP framework).40 The PIP framework is an innovative instrument regulating for the first time the entire cycle of pandemic influenza surveillance and response through the sharing of viruses (PIP biological materials) as well as of benefits deriving from the production of diagnostics, antiviral medicines, and vaccines. It seeks to enhance global equity through an explicit requirement for recipients of PIP biological material to equitably share benefits financially or in kind.41 This requirement is particularly relevant for pharmaceutical companies and academic institutions performing research and development of medical products—notably vaccines—using PIP biological material received from laboratories participating in GISRS. The tool to ensure compliance with PIP requirements consists of two ‘standard material transfer agreements’ (MTAs)—that is, contractual arrangements between the provider and the recipient of PIP biological material. They must accompany, respectively, the movement of the latter among the laboratories and research centers constituting GISRS (MTA1) and the transfer of such material to pharmaceutical companies or research institutions outside the GISRS network (MTA2). The MTAs are binding contracts and should ensure the enforceability of the otherwise recommendatory terms of PIP. Remarkably, WHO has the function to guarantee compliance with the package of PIP commitments since MTA2 must be concluded between the latter and a recipient outside GISRS even though WHO does not have physical control or legal title over PIP biological material, which is transferred directly between the institutions concerned.

PIP arguably represents a breakthrough in the global governance of pathogenic risks; its implementation has been successful, even though it has not yet generated the anticipated level of financial resources.42 At the same time, PIP covers a sub-set of a single class of pathogens, thus leaving open the legal conditions for sharing other pathogens of public health importance. The question has become more urgent as a consequence of the entry into force in 2014 of the Nagoya Protocol to the CBD, which spells out in detail the benefit-sharing obligations provided by Article 15 of the CBD.43 (p. 691) The protocol was negotiated alongside PIP and the question of access to pathogens was among its most controversial features.44 The protocol addresses the peculiar challenges of pathogen-sharing in two ways. Article 4 strikes a balance with relevant international instruments compatible with the objectives and even envisages carving out of its scope ‘specialized international access and benefit-sharing instruments . . . in respect of the specific genetic resource covered.’

That provision had mostly in mind existing treaties on the sharing of biological resources such as the FAO International Treaty on Plant Genetic Resources for Food and Agriculture,45 but it could also apply to the non-binding PIP framework as long as biological material is shared in accordance with the purposes of the CBD and the Nagoya Protocol.46 It does not apply, however, to any other human pathogens—including seasonal influenza viruses—because they are not covered by a specialized instrument such as the PIP framework. Article 8 (b) of the Protocol, moreover, requires parties to facilitate ‘expeditious access to genetic resources’ as well as to benefits ‘including access to affordable treatment by those in need’ in cases of ‘present or imminent [health] emergencies . . . as determined nationally or internationally.’

Those two provisions should provide sufficient reassurance that the bilateral approach of the CBD and the Nagoya Protocol will not interfere with essential public health needs.47 This particular issue, however, is still work in progress within WHO; member states in 2017 expressed mixed views as to the public health implications of the Nagoya Protocol,48 which forms part of the holistic discussion on global health security prompted by the Ebola crisis. It is striking, however, that the possibility of negotiating a dedicated binding instrument to regulate pathogen sharing on a general basis has not been considered at all.

Conclusion

The construction of a sustainable global system for collective preparedness and response is essential. It is made even more urgent by the awareness that pandemics of new or mutating diseases are inevitable, and that the spread of antimicrobial resistance will make international response much more challenging. The political, institutional, and normative developments summarized above point out that a credible and sustainable international system must be composed of multiple interconnecting elements that should complement and reinforce one another and thus require some form of coordination.

The main themes that emerge are the need for policy coherence among disparate fields of international law and public policy, the need for agreed governance principles on which a legal and operational framework can rely, and the unresolved question of who in the twenty-first century is responsible for funding global functions, and how. The UN system is at the intersection of such complex processes. However, it risks being subsumed by a broader global security agenda or being relegated to a technical and (p. 692) operational role, rather than leading the definition and enforcement of the principles and policies of global health security.

Notes:

(1.) David Fidler, International Law and Infectious Diseases (Oxford: Clarendon Press, 1999), 22–23; Hélène De Pooter, Le Droit International Face Aux Pandémies: Vers un Système de Sécurité Sanitaire International? (Paris: Pedone, 2015), 28–43.

(2.) Gian Luca Burci and Claude-Henri Vignes, World Health Organization (The Hague, Netherlands: Kluwer Law International, 2004), 160–165.

(3.) See also Health in the 2030 Agenda for Sustainable Development, WHA resolution 69.11, 28 May 2016.

(4.) World Health Organization, The First Ten Years of the World Health Organization (Geneva: WHO, 1958), 149–250.

(5.) World Health Organization, International Health Regulations (1969), 3rd edn. (Geneva: WHO, 1983). For a general overview of the IHR (1969), Fidler, International Law and Infectious Diseases, 58–80; and Burci, Vignes, World Health Organization, 134–141.

(6.) For a broader analysis of the collapse of the ‘classical regime’ for infectious disease control, see David Fidler, ‘From International Sanitary Conventions to Global Health Security: The New International Health Regulations,’ Chinese Journal of International Law 4, no. 2 (2005): 325–392.

(7.) WHO, International Health Regulations (2005), 3rd edn. (Geneva: WHO, 2016). All member states of WHO are parties to the IHR as well as Liechtenstein and the Holy See.

(8.) Defined in Article 1 of the regulations as ‘a manifestation of disease or an occurrence that creates a potential for disease.’

(9.) A PHEIC is loosely defined in Article 1 as ‘an extraordinary event which is determined . . . (i) to constitute a public health risk to other States through the international spread of disease and (ii) to potentially require a coordinated international response; …’ .

(10.) A summary of the WHO’s actions under the IHR can be found at www.who.int/ihr/procedures/ihr_committees/en/.

(11.) Trygve Ottersen, Steven J. Hoffman, and Gaëlle Groux, ‘Ebola Again Shows the International Health Regulations Are Broken: What Can Be Done Differently to Prepare for the Next Epidemic?’ American Journal of Law and Medicine 42 (2016): 356–392.

(12.) Identical letters dated 17 September 2014 from the Secretary-General Addressed to the President of the General Assembly and the President of the Security Council, UN document A/69/389, 18 September 2014.

(13.) The review launched within WHO and the UN, respectively, are World Health Organization, Report of the Ebola Interim Assessment Panel, July 2015, www.who.int/csr/resources/publications/ebola/ebola-panel/en; Report of the Review Committee on the Role of the International Health Regulations (2005) in the Ebola Outbreak Response (A69/21), 13 May 2016; Protecting Humanity from Future Health Crises—Report of the High-level Panel on the Global Response to Health Crises, General Assembly document A/70/723, 9 February 2016. The main academic reviews are Suerie Moon et al., ‘Will Ebola Change the Game? Ten Essential Reforms before the Next Pandemic. The Report of the Harvard- LSHTM Independent Panel on the Global Response to Ebola,’ The Lancet 386 (November 2015), 2204–2221; Commission on a Global Health Risk Framework for the Future, The Neglected Dimension of Global Security: A Framework to Counter Infectious Disease Crises (Washington, D.C.: National Academy of Medicine, 2016).

(14.) Commission on Human Security, Human Security Now (New York: Commission on Human Security, 2003). For a critical approach to the concept of human security, S. Neil MacFarlane and Yuen Foong Khong, Human Security and the UN: A Critical History (Bloomington: Indiana University Press, 2006).

(15.) A More Secure World: Our Shared Responsibility. Report of the High-Level Panel on Threats, Challenges and Changes, UN document A/59/565, 2 December 2004.

(16.) National Security Strategy of the United States (2002) available at www.state.gov/documents/organization/63562.pdf; and National Strategy for Homeland Security (2002), available at www.dhs.gov/sites/default/files/publications/nat-strat-hls-2002.pdf. See also David Fidler, ‘Caught between Paradise and Power: Public Health, Pathogenic Threats, and the Axis of Illness,’ McGeorge Law Review 35, no. 45 (2004): 65.

(17.) Security Council 4087th Meeting ‘The Impact of AIDS on Peace and Security in Africa’ (UN document S/PV.4087), 10 January 2000.

(18.) High-level Panel on Threats, Challenges and Change, A More Secure World: Our Shared Responsibility—Report of the High-level Panel on Threats, Challenges and Change (UN document A/59/565), 2 December 2004, 26–27, 30, 44–45.

(19.) G7 Ise-Shima Vision for Global Health, 27 May 2016, www.mofa.go.jp/files/000160273.pdf.

(20.) Alex de Waal, ‘Militarizing Global Health,’ Boston Review, 11 November 2014, 1–7.

(21.) Debra L. Delaet, ‘Whose Interests is the Securitization of Health Serving?,’ in Routledge Handbook of Global Health Security, ed. Simon Rushton and Jeremy Youde (New York: Routledge, 2015), 339–348.

(22.) Alex de Waal, ‘Reframing Governance, Security and Conflict in the Light of HIV/AIDS: A Synthesis of Findings from the AIDS, Security and Conflict Initiative,’ Social Science & Medicine 70 (January 2010): 114–120.

(23.) Lawrence O. Gostin, Global Health Law (Cambridge, Mass.: Harvard University Press, 2014), 383–411.

(24.) De Waal, Militarizing Global Health, 7.

(25.) Special Session on the Ebola Emergency, Executive Board resolution EBSS3.R1, 25 January 2015.

(26.) Report of the Independent Oversight and Advisory Committee for the WHO Health Emergencies Programme, WHO document A/70/8, 1 May 2017, 7.

(27.) Health Workforce Coordination in Emergencies with Health Consequences, WHO document A/70/11, 13 April 2017.

(28.) Report of the High-level Panel on the Global Response to Health Crises, 16

(29.) The World Bank, Pandemic Emergency Facility: Frequently Asked Questions, www.worldbank.org/en/topic/pandemics/brief/pandemic-emergency-facility-frequently-asked-questions.

(30.) Report of the Review Committee on Second Extensions for Establishing National Public Health Capacities and on IHR Implementation, (WHO document A68/22 Add.1), 27 March 2015.

(31.) Information about the GHSA is available at www.ghsagenda.org.

(32.) A description of the JEET process and a list of countries that have undergone the assessment is available at www.ghsagenda.org/assessments.

(33.) Report of the Review Committee on the Role of the International Health Regulations (2005) in the Ebola Outbreak Response, 62–63.

(34.) Ibid., 64.

(35.) Report of the Ebola Interim Assessment Panel, 13.

(36.) Implementation of the International Health Regulations (2005)—Global Implementation Plan, WHO document A/70/16, 18 May 2017, 9.

(38.) David P. Fidler, Indonesia’s Decision to Withhold Influenza Virus Samples from the World Health Organization: Implications for International Law, www.asil.org/insights/year/2007.

(39.) 1760 UNTS, 79. Article 2 defines ‘genetic resources’ as ‘genetic material of actual or potential value,’ and ‘genetic material’ as ‘any material of plant, animal, microbial or other origin containing functional units of heredit.’ Even though including harmful pathogens in the scope of the CBD seemed to pervert its objective under Article 1 of pursuing ‘the conservation of biological diversity, the sustainable use of its components . . . ,’ the consideration of the commercial value of the exploitation of human pathogens has been decisive toward the acquiescence of the Parties.

(40.) Pandemic Influenza Preparedness: Sharing of Influenza Viruses and Access to Vaccines and Other Benefits, WHA resolution WHA64.5, 24 May 2011.

(41.) David P. Fidler and Lawrence O. Gostin, ‘The WHO Pandemic Influenza Preparedness Framework: A Milestone in Global Governance for Health,’ Journal of the American Medical Association 306 (July 2011), 200–201.

(42.) A recommendation to extend PIP to seasonal influenza is under consideration by WHO member states; Review of the Pandemic Influenza Preparedness Framework, WHO document A70/17, 10 April 2017.

(43.) Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the Convention on Biological Diversity, UN document UNEP/CBD/COP/DEC/X/1, 29 October 2010. The Protocol had 99 Parties as of May 2017.

(44.) Matthias Buck and Clare Hamilton, ‘The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from Their Utilization to the Convention on Biological Diversity,’ Review of European Community and International Environmental Law 20 (2011): 47–61, in particular 58–59.

(45.) Adopted on 3 November 2001, entered into force on 29 June 2004, text available at www.fao.org/plant-treaty/overview/texts-treaty/en/.

(46.) This is the reading of Marie Wilke, ‘A Healthy Look at the Nagoya ProtocolImplications for Global Health Governance,’ in The 2010 Nagoya Protocol on Access and Benefit-Sharing in Perspective: Implications for International Law and Implementation Challenges, ed. Elisa Morgera, Matthias Buck, and Elsa Tsiounami (Leiden, Brill, 2013), 145.

(47.) This is the position of Wilke, ‘A Healthy Look at the Nagoya Protocol—Implications for Global Health Governance,’ 147.

(48.) Public Health Implications of the Implementation of the Nagoya Protocol, WHO document EB140/15, 23 December 2016.